The Recall Desk
HighFDA (Devices)·Z-0153-2021·Announced 2020-10-28

Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Defects

Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where a breach of the sterile barrier could lead to infection, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Smith & Nephew, Inc. is recalling OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK Absorbable Suture Anchors (Product Number: 72201996). The recall involves specific batch numbers: 2012912, 2017844, 2019840, 2021496, 2024714, 2033500, 2049663, 2052725, and 2055727. The products were distributed nationwide and to numerous foreign countries.

The recall was initiated because the product packaging may have an improper or incomplete seal on the pouch surrounding the sterile product. This defect may result in a breach of the sterile barrier created by the pouch, potentially compromising the sterility of the device.

Healthcare providers and facilities should check their inventory for the affected product numbers and batch numbers. If the product is found, it should be removed from use and returned to Smith & Nephew, Inc. according to their instructions.

The recalled product

Product
OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 40 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 40 products in this recall →